Pharmaceutical quality worksheet

Advanced Disintegration Test Calculator

Configure the method, record every dosage unit, validate operating conditions, apply staged acceptance logic, investigate exceptions, and export a complete laboratory report.

Validation notice: This demonstration is not a validated GxP system. Confirm every method, limit, apparatus, and decision against current approved documents.

Product and test identity

Traceability

Pharmacopoeia, method, and specification

Configurable controls
minsec
minsec
Method-control reminder: Pharmacopoeial harmonization does not remove product-specific, regional, registered, or dosage-form requirements. Keep all presets editable.

Apparatus and operating conditions

Equipment suitability
mm
mm
mm
mm
Apparatus recommendation: Enter the longest axis for a recommendation.
mL
°C
±°C
°C
°C
°C
°C
mm
mm
mm
mL

Individual dosage-unit timing

Each included unit requires both an endpoint time and endpoint classification. Manual overrides are recorded and should be justified.
1
Position 1
Initial stage
00:00.0
2
Position 2
Initial stage
00:00.0
3
Position 3
Initial stage
00:00.0
4
Position 4
Initial stage
00:00.0
5
Position 5
Initial stage
00:00.0
6
Position 6
Initial stage
00:00.0
7
Position 7
Additional stage
00:00.0
8
Position 8
Additional stage
00:00.0
9
Position 9
Additional stage
00:00.0
10
Position 10
Additional stage
00:00.0
11
Position 11
Additional stage
00:00.0
12
Position 12
Additional stage
00:00.0
13
Position 13
Additional stage
00:00.0
14
Position 14
Additional stage
00:00.0
15
Position 15
Additional stage
00:00.0
16
Position 16
Additional stage
00:00.0
17
Position 17
Additional stage
00:00.0
18
Position 18
Additional stage
00:00.0

Delayed-release and sequential-stage controls

Acid and buffer stages
minutes
minutes
minutes

OOS, OOT, deviations, and retesting

Investigation controls

Analyst, reviewer, and approval

Demonstration signatures
Analyst statement

I certify that the recorded observations represent the test performed and that changes are documented.

Reviewer statement

I reviewed the method, raw data, calculations, warnings, exceptions, and final decision.

Reports, data exchange, and saved records

CSV, PDF, JSON, LIMS

Browser and session storage are convenience features only. They do not provide validated retention, security, electronic signatures, or disaster recovery.

Session audit trail

0 entries

No session audit entries exist yet.

Formulae used

Transparent calculations
Individual time
Tᵢ = endpoint timeᵢ − start timeᵢ
The timer stores the elapsed time for each position.
Mean time
T̄ = ΣTᵢ / n
The mean is descriptive and does not replace individual limits.
Sample standard deviation
s = √[Σ(Tᵢ − T̄)² / (n − 1)]
Calculated when at least two completed units exist.
Relative standard deviation
RSD (%) = (s / T̄) × 100
Displayed as a descriptive variability indicator.
Pass rate
Pass rate (%) = passing units / tested units × 100
Excluded or incomplete units are not counted as completed tests.
Range and IQR
Range = Tₘₐₓ − Tₘᵢₙ; IQR = Q₃ − Q₁
Percentiles use linear interpolation over sorted values.

How to use this calculator

Controlled workflow
  1. Identify the product, batch, market, sample source, and testing purpose.
  2. Select the applicable pharmacopoeia and record the controlled method revision.
  3. Enter the approved time limit and exact staged acceptance requirements.
  4. Record dimensions and verify the apparatus against the approved method.
  5. Confirm instrument calibration, qualification, basket, bath, and probe identities.
  6. Enter medium preparation, volume, pH, temperature, movement, and stroke data.
  7. Include the required basket positions and start the individual timers.
  8. Stop each timer at the approved endpoint and classify the remaining material.
  9. Calculate results, review every warning, and investigate any abnormal condition.
  10. Complete delayed-release stages, deviations, attestations, and reviewer comments.
  11. Export the raw data and controlled report before closing the session.

Embedded laboratory guidance and system requirements

Endpoint discipline

Disintegration and dissolution are different measurements. The calculator never estimates dissolved drug percentage from a disintegration time.

Analysts should apply the endpoint description from the controlled method. A remaining firm core, mesh lodging, or equipment interruption needs documented review.

Data integrity

Raw observations should be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.

This page records demonstration audit entries. A production system requires validated access control, immutable audit trails, backups, and controlled electronic signatures.

Method governance

Do not infer product limits from dosage-form names alone. The registered dossier, monograph, specification, and approved SOP govern the test.

Method versions, regional requirements, apparatus differences, discs, media, and staged rules must remain configurable.

Required master data

  • Product and strength
  • Dosage form and release type
  • Method and specification versions
  • Equipment identities
  • Analyst and reviewer identities

Required raw data

  • Every included position
  • Individual elapsed time
  • Endpoint classification
  • Disc and detection mode
  • Observed abnormal behavior

Condition controls

  • Medium identity and volume
  • Temperature profile
  • Cycle rate and stroke
  • Calibration validity
  • Acid and buffer stages

Review controls

  • Missing-data detection
  • Specification confirmation
  • Deviation linkage
  • Original-result retention
  • Approval and report export
Ready to evaluate: complete required identity, method, condition, time, and endpoint fields.
Reference panel

Disintegration test help

Apparatus selection

Measure the dosage unit along its longest axis. Use the calculator recommendation only as a screening prompt. The approved method remains authoritative.

Initial and additional stages

The staged engine allows an initial quantity, an additional quantity, an initial-failure allowance, and a required total passing count. Configure all four values.

Individual endpoint

A completed time is not enough. Select the endpoint classification that describes the material remaining in the basket.

Manual override

A forced pass or fail changes the calculated unit status. Explain the reason in the unit notes and investigation record.

Temperature excursion

Enter the lowest and highest recorded values. The validation engine compares them with the target and tolerance.

Cycle rate and stroke

Record actual observed or verified values. Out-of-range values create test-invalidating warnings.

Delayed-release products

Record acid resistance before buffer-stage disintegration. Do not use immediate-release logic without approved justification.

Discs

Disc use can depend on the dosage form, method, or product behavior. Record the policy and the actual unit-level usage.

Floating and sticking

Document abnormal behavior even when the final time meets the limit. Such behavior may affect method suitability or interpretation.

OOS and OOT

A failing calculator decision is not an authorization to retest. Follow the approved investigation and authorization workflow.

Audit trail

The included audit list is session based and editable through reset. It is not a compliant immutable audit trail.

PDF report

The PDF button creates a client-side summary using the current browser data. Review the generated report before controlled use.

CSV export

CSV contains unit-level timing and endpoint data. Spreadsheet software may reformat values, so preserve the original export.

LIMS JSON

The LIMS package is a generic demonstration schema. Map and validate it before integrating with a real LIMS.

Electronic signatures

Checkbox attestations are not secure electronic signatures. A production system needs unique credentials, signature meaning, linkage, and validation.

Statistics

Mean, median, standard deviation, RSD, quartiles, and range are descriptive. Individual and staged specifications drive the decision.

Incomplete units

An included position without both a time and endpoint is counted as missing. Exclude it only with a documented reason.

Browser draft

Local storage can help during development. It is not reliable controlled storage and may be cleared by the browser.

Session save

PHP session records disappear when the server session expires. Use a database with access control for production records.

Current standards

Always check the current pharmacopoeia, official supplement, registered dossier, approved method, and change-control status.

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Important Note: All the Calculators listed in this site are for educational purpose only and we do not guarentee the accuracy of results. Please do consult with other sources as well.